# ORASURE TECHNOLOGIES INC (OSUR)

Informational only - not investment advice.

CIK: 0001116463
SIC: 3841 Surgical & Medical Instruments & Apparatus
SIC breadcrumb: [Manufacturing](/division/D/) > [SIC Major Group 38](/major-group/38/) > [SIC 3841 Surgical & Medical Instruments & Apparatus](/industry/3841/)
Latest 10-K filed: 2026-03-09
SEC page: https://www.sec.gov/edgar/browse/?CIK=1116463
Filing source: https://www.sec.gov/Archives/edgar/data/1116463/000111646326000016/osur-20251231.htm

## Selected Fundamentals
| Metric | Value | Unit | FY | Filed |
| --- | ---: | --- | ---: | --- |
| Revenue | 115021000 | USD | 2025 | 2026-03-09 |
| Net income | -68731000 | USD | 2025 | 2026-03-09 |
| Assets | 403168000 | USD | 2025 | 2026-03-09 |

## Financials

Annual standardized facts from SEC companyfacts as of latest extracted filing date 2026-03-09. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001116463.json. Derived margins, ratios, and free cash flow are computed from the extracted annual SEC facts.

| Metric | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
| --- | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: |
| Revenue | 128,198,000 | 167,064,000 | 181,743,000 | 154,605,000 | 171,721,000 | 233,674,000 | 387,479,000 | 405,472,000 | 185,827,000 | 115,021,000 |
| Net income | 19,720,000 | 30,948,000 | 20,396,000 | 16,656,000 | -14,922,000 | -22,998,000 | -17,133,000 | 53,655,000 | -19,500,000 | -68,731,000 |
| Operating income | 20,265,000 | 40,238,000 | 28,429,000 | 18,611,000 | -5,177,000 | -10,164,000 | -22,156,000 | 32,684,000 | -28,250,000 | -71,969,000 |
| Gross profit | 88,027,000 | 98,956,000 | 113,613,000 | 94,583,000 | 101,868,000 | 117,600,000 | 148,438,000 | 171,652,000 | 79,390,000 | 48,198,000 |
| Diluted EPS | 0.35 | 0.51 | 0.33 | 0.27 | 0.22 | -0.32 | -0.24 | 0.72 | -0.26 | -0.94 |
| Operating cash flow | 24,598,000 | 28,156,000 | 39,090,000 | 9,804,000 | 5,807,000 | -35,382,000 | -47,202,000 | 141,583,000 | 27,374,000 | -49,023,000 |
| Capital expenditures | 4,353,000 | 4,337,000 | 6,344,000 | 9,314,000 | 26,674,000 | 21,893,000 | 6,774,000 | 5,802,000 | 3,797,000 | 4,197,000 |
| Share buybacks | 3,444,000 | 1,240,000 | 3,592,000 | 3,712,000 | 2,088,000 | 2,113,000 | 2,254,000 | 0.00 | 0.00 | 15,040,000 |
| Assets | 207,935,000 | 296,201,000 | 315,571,000 | 349,295,000 | 454,472,000 | 460,990,000 | 444,180,000 | 482,845,000 | 479,659,000 | 403,168,000 |
| Liabilities |  |  | 32,193,000 | 42,150,000 | 55,901,000 | 80,457,000 | 79,755,000 | 52,174,000 | 69,321,000 | 62,341,000 |
| Stockholders' equity | 185,850,000 | 258,081,000 | 283,378,000 | 307,145,000 | 398,571,000 | 380,533,000 | 364,425,000 | 430,671,000 | 410,338,000 | 340,827,000 |
| Cash and cash equivalents | 107,959,000 | 71,029,000 | 88,438,000 | 75,715,000 | 160,802,000 | 116,762,000 | 83,980,000 | 290,407,000 | 267,763,000 | 199,278,000 |
| Free cash flow | 20,245,000 | 23,819,000 | 32,746,000 | 490,000 | -20,867,000 | -57,275,000 | -53,976,000 | 135,781,000 | 23,577,000 | -53,220,000 |

### Ratios

ROE and ROA use period-end equity/assets. Liabilities / equity uses total liabilities divided by stockholders' equity. Current ratio uses current assets divided by current liabilities when both are reported.

| Metric | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
| --- | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: |
| Net margin | 15.38% | 18.52% | 11.22% | 10.77% | -8.69% | -9.84% | -4.42% | 13.23% | -10.49% | -59.76% |
| Operating margin | 15.81% | 24.09% | 15.64% | 12.04% | -3.01% | -4.35% | -5.72% | 8.06% | -15.20% | -62.57% |
| Return on equity | 10.61% | 11.99% | 7.20% | 5.42% | -3.74% | -6.04% | -4.70% | 12.46% | -4.75% | -20.17% |
| Return on assets | 9.48% | 10.45% | 6.46% | 4.77% | -3.28% | -4.99% | -3.86% | 11.11% | -4.07% | -17.05% |
| Liabilities / equity |  |  | 0.11 | 0.14 | 0.14 | 0.21 | 0.22 | 0.12 | 0.17 | 0.18 |
| Current ratio | 9.02 | 6.88 | 7.84 | 6.86 | 6.21 | 4.40 | 4.71 | 9.77 | 9.95 | 6.58 |

## Quarterly

Quarterly standardized facts from SEC companyfacts as of latest extracted filing date 2026-05-08. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001116463.json.

Flow metrics use discrete quarter-length periods from 10-Q/10-Q/A filings. Q4 revenue and net income are derived only when annual FY and nine-month YTD facts exist for the same fiscal year; derived Q4 values are labeled. EPS Q4 is not derived.

| Quarter | End date | Revenue | Net income | Diluted EPS | Method |
| --- | --- | ---: | ---: | ---: | --- |
| 2022-Q2 | 2022-06-30 |  |  | -0.26 | reported discrete quarter |
| 2022-Q3 | 2022-09-30 |  |  | 0.07 | reported discrete quarter |
| 2023-Q1 | 2023-03-31 |  |  | 0.37 | reported discrete quarter |
| 2023-Q2 | 2023-03-31 |  | 27,219,000 |  | reported discrete quarter |
| 2023-Q2 | 2023-06-30 | 85,441,000 |  | -0.07 | reported discrete quarter |
| 2023-Q3 | 2023-06-30 |  | -4,796,000 |  | reported discrete quarter |
| 2023-Q3 | 2023-09-30 | 89,187,000 |  | 0.15 | reported discrete quarter |
| 2023-Q4 | 2023-12-31 | 75,881,000 | 20,073,000 |  | derived Q4 = FY annual - nine-month YTD |
| 2024-Q1 | 2024-03-31 | 54,132,000 | -3,584,000 | -0.05 | reported discrete quarter |
| 2024-Q2 | 2024-03-31 |  | -3,584,000 |  | reported discrete quarter |
| 2024-Q2 | 2024-06-30 | 54,335,000 |  | -0.01 | reported discrete quarter |
| 2024-Q3 | 2024-06-30 |  | -615,000 |  | reported discrete quarter |
| 2024-Q3 | 2024-09-30 | 39,915,000 |  | -0.06 | reported discrete quarter |
| 2024-Q4 | 2024-12-31 | 37,445,000 | -10,794,000 |  | derived Q4 = FY annual - nine-month YTD |
| 2025-Q1 | 2025-03-31 | 29,931,000 | -16,040,000 | -0.21 | reported discrete quarter |
| 2025-Q2 | 2025-03-31 |  | -16,040,000 |  | reported discrete quarter |
| 2025-Q2 | 2025-06-30 | 31,242,000 |  | -0.26 | reported discrete quarter |
| 2025-Q3 | 2025-06-30 |  | -19,693,000 |  | reported discrete quarter |
| 2025-Q3 | 2025-09-30 | 27,085,000 |  | -0.19 | reported discrete quarter |
| 2025-Q4 | 2025-12-31 | 26,763,000 | -19,286,000 |  | derived Q4 = FY annual - nine-month YTD |
| 2026-Q1 | 2026-03-31 | 27,925,000 | -22,377,000 | -0.32 | reported discrete quarter |

## Macro Cross-References
- [CPIAUCSL](/indicator/CPIAUCSL/): Consumer Price Index for All Urban Consumers: All Items in U.S. City Average
- [UNRATE](/indicator/UNRATE/): Unemployment Rate
- [FEDFUNDS](/indicator/FEDFUNDS/): Federal Funds Effective Rate
- [CES0500000003](/indicator/CES0500000003/): Average Hourly Earnings of All Employees, Total Private
- [DFEDTARU](/indicator/DFEDTARU/): Federal Funds Target Range - Upper Limit
- [DFEDTARL](/indicator/DFEDTARL/): Federal Funds Target Range - Lower Limit
- [DGS3MO](/indicator/DGS3MO/): Market Yield on U.S. Treasury Securities at 3-Month Constant Maturity
- [DGS2](/indicator/DGS2/): Market Yield on U.S. Treasury Securities at 2-Year Constant Maturity
- [DGS10](/indicator/DGS10/): Market Yield on U.S. Treasury Securities at 10-Year Constant Maturity
- [DGS30](/indicator/DGS30/): Market Yield on U.S. Treasury Securities at 30-Year Constant Maturity
- [T10Y2Y](/indicator/T10Y2Y/): 10-Year Treasury Constant Maturity Minus 2-Year Treasury Constant Maturity
- [CPILFESL](/indicator/CPILFESL/): Consumer Price Index for All Urban Consumers: All Items Less Food and Energy
- [CPIUFDSL](/indicator/CPIUFDSL/): Consumer Price Index for All Urban Consumers: Food
- [CPIENGSL](/indicator/CPIENGSL/): Consumer Price Index for All Urban Consumers: Energy
- [CUSR0000SAH1](/indicator/CUSR0000SAH1/): Consumer Price Index for All Urban Consumers: Shelter
- [PCEPI](/indicator/PCEPI/): Personal Consumption Expenditures: Chain-type Price Index
- [PCEPILFE](/indicator/PCEPILFE/): Personal Consumption Expenditures Excluding Food and Energy: Chain-type Price Index
- [PPIACO](/indicator/PPIACO/): Producer Price Index by Commodity: All Commodities
- [T10YIE](/indicator/T10YIE/): 10-Year Breakeven Inflation Rate
- [U6RATE](/indicator/U6RATE/): Total Unemployed, Plus All Marginally Attached Workers Plus Total Employed Part Time for Economic Reasons
- [PAYEMS](/indicator/PAYEMS/): All Employees, Total Nonfarm
- [CIVPART](/indicator/CIVPART/): Labor Force Participation Rate
- [EMRATIO](/indicator/EMRATIO/): Employment-Population Ratio
- [UNEMPLOY](/indicator/UNEMPLOY/): Unemployed
- [CE16OV](/indicator/CE16OV/): Employment Level
- [ICSA](/indicator/ICSA/): Initial Claims
- [JTSJOL](/indicator/JTSJOL/): Job Openings: Total Nonfarm
- [JTSQUR](/indicator/JTSQUR/): Quits: Total Nonfarm
- [GDPC1](/indicator/GDPC1/): Real Gross Domestic Product
- [A191RL1Q225SBEA](/indicator/A191RL1Q225SBEA/): Real Gross Domestic Product: Percent Change from Preceding Period
- [INDPRO](/indicator/INDPRO/): Industrial Production: Total Index
- [TCU](/indicator/TCU/): Capacity Utilization: Total Index
- [HOUST](/indicator/HOUST/): New Privately-Owned Housing Units Started: Total Units
- [PERMIT](/indicator/PERMIT/): New Privately-Owned Housing Units Authorized in Permit-Issuing Places: Total Units
- [RSAFS](/indicator/RSAFS/): Advance Retail Sales: Retail Trade
- [PCE](/indicator/PCE/): Personal Consumption Expenditures
- [DSPIC96](/indicator/DSPIC96/): Real Disposable Personal Income
- [PSAVERT](/indicator/PSAVERT/): Personal Saving Rate
- [M2SL](/indicator/M2SL/): M2
- [BOPGSTB](/indicator/BOPGSTB/): U.S. International Trade in Goods and Services: Balance
- [MSPUS](/indicator/MSPUS/): Median Sales Price of Houses Sold for the United States
- [HSN1F](/indicator/HSN1F/): New One Family Houses Sold: United States
- [RHORUSQ156N](/indicator/RHORUSQ156N/): Homeownership Rate in the United States
- [TTLCONS](/indicator/TTLCONS/): Total Construction Spending: Total Construction in the United States
- [RRVRUSQ156N](/indicator/RRVRUSQ156N/): Rental Vacancy Rate in the United States
- [TOTALSL](/indicator/TOTALSL/): Total Consumer Credit Owned and Securitized
- [REVOLSL](/indicator/REVOLSL/): Revolving Consumer Credit Owned and Securitized
- [DRCCLACBS](/indicator/DRCCLACBS/): Delinquency Rate on Credit Card Loans, All Commercial Banks
- [GDP](/indicator/GDP/): Gross Domestic Product
- [GPDI](/indicator/GPDI/): Gross Private Domestic Investment
- [GCE](/indicator/GCE/): Government Consumption Expenditures and Gross Investment
- [PCEC](/indicator/PCEC/): Personal Consumption Expenditures
- [NETEXP](/indicator/NETEXP/): Net Exports of Goods and Services
- [GFDEBTN](/indicator/GFDEBTN/): Federal Debt: Total Public Debt
- [GFDEGDQ188S](/indicator/GFDEGDQ188S/): Federal Debt: Total Public Debt as Percent of Gross Domestic Product
- [FYFSD](/indicator/FYFSD/): Federal Surplus or Deficit
- [FGRECPT](/indicator/FGRECPT/): Federal Government Current Receipts
- [FGEXPND](/indicator/FGEXPND/): Federal Government: Current Expenditures
- [MANEMP](/indicator/MANEMP/): All Employees, Manufacturing
- [USCONS](/indicator/USCONS/): All Employees, Construction
- [USTRADE](/indicator/USTRADE/): All Employees, Retail Trade
- [USFIRE](/indicator/USFIRE/): All Employees, Financial Activities
- [USGOVT](/indicator/USGOVT/): All Employees, Government
- [AWHAETP](/indicator/AWHAETP/): Average Weekly Hours of All Employees, Total Private
- [DGORDER](/indicator/DGORDER/): Manufacturers' New Orders: Durable Goods
- [NEWORDER](/indicator/NEWORDER/): Manufacturers' New Orders: Nondefense Capital Goods Excluding Aircraft
- [BUSINV](/indicator/BUSINV/): Total Business Inventories
- [EXPGS](/indicator/EXPGS/): Exports of Goods and Services
- [IMPGS](/indicator/IMPGS/): Imports of Goods and Services
- [IR](/indicator/IR/): Import Price Index (End Use): All Commodities
- [PPIFIS](/indicator/PPIFIS/): Producer Price Index by Commodity: Final Demand

## Latest quarter (10-Q)

Latest 10-Q source: https://www.sec.gov/Archives/edgar/data/1116463/000111646326000041/osur-20260331.htm

Extracted structurally from real Item 2 body heading to real Item 3/4 boundary.
Confidence: high
Filing date: 2026-05-08
Report date: 2026-03-31

Item 2.    Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis of the Company's financial condition and results of operations should be read in conjunction with (i) the Company's unaudited condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and (ii) the Company's audited consolidated financial statements and related notes and management’s discussion and analysis of financial condition and results of operations included in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 filed with the Securities and Exchange Commission on March 9, 2026. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to the Company's plans and strategy for its business and impact and potential impacts on its business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including, without limitation, those factors set forth in the “Risk Factors” section of the Company's Annual Report on Form 10-K for the year ended December 31, 2025 and the “Risk Factors” section of subsequent Quarterly Reports on Form 10-Q, the Company's actual results or timing of certain events could differ materially from the results or timing described in, or implied by, these forward-looking statements.

Business Overview

The Company's business consists of the development, manufacture, marketing, sale and distribution of simple, easy to use diagnostic products and specimen collection devices using its proprietary technologies, as well as other diagnostic products including immunoassays and other in vitro diagnostic tests that are used on other specimen types. The Company's diagnostic products include tests for diseases including HIV, Hepatitis C, Syphilis, Sickle Cell and COVID-19 that are performed on a rapid basis at the point of care. These products are sold in the United States and internationally to various clinical laboratories, hospitals, clinics, community-based organizations, and other public health organizations, distributors, government agencies, physicians’ offices, and commercial and industrial entities. The Company's HIV and COVID-19 products are also sold in a consumer-friendly format in the over-the-counter ("OTC") market in the U.S. and, in the case of the HIV and HCV products, as a self-test to individuals in a number of other countries, including, for the HIV products, as an oral swab in-home test for HIV-1 and HIV-2 in Europe, and for the HCV products, as an OTC test. In December 2025,

20

Table of Contents

the Company submitted a 510(k) to the FDA for clearance of its rapid molecular self-test for CT/NG, which is currently under review.

The Company's business also includes sample management solutions and services that are used by clinical laboratories, direct-to-consumer laboratories, researchers, pharmaceutical companies, and animal health service and product providers. The revenues from sample management solutions are derived from product sales to commercial customers and sales into the academic and research markets. Customers span the disease risk management, diagnostics, pharmaceutical, biotech, and companion animal market segments. The Company has also developed collection devices for the emerging microbiome market, which focuses on studying microbiomes and their effect on human and animal health. The Company also has a urine collection device which allows for the volumetric collection of first void urine. Initial sales of this product for research use only are occurring primarily through distributors and collaborations in the liquid biopsy and sexually transmitted disease markets. In December 2025, the Company also submitted a 510(k) to the FDA for clearance of its Colli-Pee® at-home urine collection device for sexually transmitted infections, which is currently under review.

Risk Assessment Testing

During the third quarter of 2024, the Company announced the discontinuance of sales of its risk assessment product line, which was completed in the second quarter of 2025. Sales of its risk assessment products did not contribute to revenues during the three months ended March 31, 2026. Sales of its risk assessment products contributed $1.4 million to revenues during the three months ended March 31, 2025. During the first quarter of 2025, the Company sold certain assets that made up the risk assessment product line including certain intellectual property, contracts, permits, and equipment.

21

Table of Contents

Results of Operations (all dollar amounts in tables are presented in thousands)

For the three months ended March 31, 2026 compared to March 31, 2025.

CONSOLIDATED NET REVENUES

The table below shows total consolidated net revenues for the three months ended March 31, 2026 and 2025:

For the Three Months Ended March 31,

Dollars

% Change

Percentage of Total Net Revenues

2026

2025

2026

2025

Diagnostics (1)

$

16,866 

$

17,689 

(5)

%

60 

%

59 

%

Sample Management Solutions (2)

9,058 

9,110 

(1)

32 

30 

Other products and services (3)

434 

321 

35 

2 

1 

COVID-19 Diagnostics

18 

457 

(96)

— 

2 

Risk Assessment Testing (4)

— 

1,420 

(100)

— 

5 

Net product and services revenues

26,376 

28,997 

(9)

94 

97 

Non-product and services revenues (5)

1,549 

934 

66 

6 

3 

Net revenues

$

27,925 

$

29,931 

(7)

%

100 

%

100 

%

(1)Includes HIV, HCV, Syphilis, SickleSCAN® and SureQuick® product revenues.

(2)Includes Genomics, Microbiome, and Colli-Pee® product revenues.

(3)Includes COVID-19 Sample Management Solutions product revenues.

(4)Includes substance abuse testing product revenues.

(5)Includes funded research and development contracts, royalty income and grant revenues.

Product and Services Revenues

Consolidated net revenues decreased 7% to $27.9 million for the three months ended March 31, 2026 from $29.9 million for the three months ended March 31, 2025.

Sales of the Company's Diagnostics products decreased 5% to $16.9 million for the three months ended March 31, 2026 from $17.7 million for the three months ended March 31, 2025. This decrease in revenues is largely due to lower international HCV revenues driven by customer ordering patterns and funding constraints. This decline in revenues was offset by an increase in Company's Syphilis product sales to new customers in the women's health market.

Sample Management Solutions revenues remained largely flat at $9.1 million for the three months ended March 31, 2026 and 2025.

COVID-19 Diagnostics sales decreased 96% to $18.0 thousand for the three months ended March 31, 2026 from $0.5 million for the three months ended March 31, 2025, due to completion of the Company's InteliSwab® tests contract with the U.S. government and lower overall demand for COVID-19 testing.

Risk Assessment Testing revenues are $0 in 2026 as the product line was discontinued and wound down in early 2025.

Non-Product and Services Revenues

Non-product and services revenues increased 66% to $1.5 million for the three months ended March 31, 2026 from $0.9 million for the three months ended March 31, 2025 primarily due to the recognition of revenue under various funded R&D contracts.

CONSOLIDATED OPERATING RESULTS

Consolidated gross profit margin increased to 42.3% for the three months ended March 31, 2026 compared to 41.1% for the three months ended March 31, 2025. The drivers of the margin increase were better absorption of fixed overhead costs

22

Table of Contents

due to operational efficiencies, improved product mix, and higher non-product revenues which contribute 100% to gross margin. An increase in scrap expense in the quarter partially offset the increases in gross margin.

Consolidated operating loss for the three months ended March 31, 2026 was $23.3 million compared to $17.8 million for the three months ended March 31, 2025. The higher operating loss reported in 2026 was largely a result of lower revenues coupled with increased research and development spend.

Research and development expenses increased 42% to $13.7 million for the three months ended March 31, 2026 from $9.6 million for the three months ended March 31, 2025 largely due to higher spend incurred for clinical trials associated with the Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG) device and the Colli-Pee® device. The increase in research and development expenses is also due to additional severance charges associated with the Company's reduction in its workforce in February 2026.

Sales and marketing expenses decreased 1% to $6.8 million for the three months ended March 31, 2026 from $6.9 million for the three months ended March 31, 2025.

General and administrative expenses increased 3% to $14.6 million for the three months ended March 31, 2026 from $14.1 million for the three months ended March 31, 2025 largely due to an increase in professional services and severance charges.

The Company recorded non-cash adjustments of $0.1 million for the three months ended March 31, 2026, reflecting the change in the estimated fair value of the Sherlock acquisition-related contingent consideration.

All of the above contributed to the Company's operating loss of $23.3 million for the three months ended March 31, 2026, which included non-cash charges of $2.8 million for stock-based compensation, $2.3 million for depreciation and amortization, and $0.1 million for the change in the estimated fair value of acquisition-related contingent consideration. The Company's operating loss of $17.8 million for the three months ended March 31, 2025 included non-cash charges of $2.7 million for stock-based compensation, $2.8 million for depreciation and amortization, and $0.5 million for the change in the estimated fair value of acquisition-related contingent consideration.

OTHER INCOME

Other income for the three months ended March 31, 2026 was $1.5 million compared to $1.8 million for the three months ended March 31, 2025. The decrease in other income is due to lower interest income and increased foreign currency losses.

CONSOLIDATED INCOME TAXES

The Company continues to believe the full valuation allowance established against its total U.S. and U.K. deferred tax asset is appropriate as the facts and circumstances necessitating the allowance have not changed. For the three months ended March 31, 2026 and 2025, the Company recorded income tax benefits of $0.4 million and $0.5 million, respectively.

Liquidity and Capital Resources

March 31, 2026

December 31, 2025

(in thousands)

Cash and cash equivalents

$

176,964 

$

199,278 

Working capital

196,697 

222,113 

The Company's cash and cash equivalents decreased to $177.0 million at March 31, 2026 from $199.3 million at December 31, 2025. The Company has $84.9 million, or 48%, of its $177.0 million of cash and cash equivalents held by DNAG, the Company's Canadian subsidiary.

The Company's working capital decreased to $196.7 million at March 31, 2026 from $222.1 million at December 31, 2025. Working capital is primarily a function of sales, purchase volumes, inventory requirements, and vendor payment terms.

Analysis of the Company's Cash Flows

Operating Activities

23

Table of Contents

During the three months ended March 31, 2026, net cash used in operating activities was $13.9 million. Cash flows from operations can be significantly impacted by factors such as timing of receipts from customers, inventory purchases, and payments to vendors. The Company's net loss of $22.4 million included non-cash charges of stock-based compensation expense of $2.8 million, depreciation and amortization expense of $2.3 million, a loss on equity investment of $1.1 million, and other non-cash charges aggregating to $0.4 million.

Changes in the Company's working capital

[Excerpt truncated for page length; source filing is linked above.]

## Latest 10-K MD&A

Extracted structurally from real Item 7 body heading to real Item 7A/8 boundary.
Confidence: high

ITEM 7.    Management’s Discussion and Analysis of Financial Condition and Results of Operations.

Statements below regarding future events or performance are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The Company's actual results could be quite different from those expressed or implied by the forward-looking statements. Factors that could affect results are discussed more fully under the Item 1A, entitled “Risk Factors,” and elsewhere in this Annual Report. Although forward-looking statements help to provide complete information about the Company, readers should keep in mind that forward-looking statements may not be reliable. Readers are cautioned not to place undue reliance on the forward-looking statements. The Company undertakes no duty to update any forward-looking statements made herein after the date of this Annual Report.

The following discussion should be read in conjunction with the consolidated financial statements contained herein and the notes thereto, along with the Section entitled “Critical Accounting Policies and Estimates,” set forth below. This section of this Annual Report on Form 10-K for the year ended December 31, 2025 (this "Annual Report") generally discusses 2025 and 2024 items and year-to-year comparisons between 2025 and 2024. Discussion of 2023 items and year-to-year comparisons between 2024 and 2023 that are not included in this Annual Report can be found in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Part II, Item 7 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.

Business Overview

The Company's business consists of the development, manufacture, marketing, sale and distribution of simple, easy to use diagnostic products and specimen collection devices using its proprietary technologies, as well as other diagnostic products including immunoassays and other in vitro diagnostic tests that are used on other specimen types. Our diagnostic products include tests for diseases including HIV, Hepatitis C, Syphilis, Sickle Cell and COVID-19 that are performed on a rapid basis at the point of care. These products are sold in the United States and internationally to various clinical laboratories, hospitals, clinics, community-based organizations, and other public health organizations, distributors, government agencies, physicians’ offices, and commercial and industrial entities. The Company's HIV and COVID-19 products are also sold in a consumer-friendly format in the OTC market in the U.S. and, in the case of the HIV and HCV products, as a self-test to individuals in a number of other countries, including, for the HIV products, as an oral swab in-home test for HIV-1 and HIV-2 in Europe, and for the HCV products, as an OTC test. In December 2025, the Company submitted a 510(k) to the FDA for clearance of its rapid molecular self-test for CT/NG, which is currently under review.

The Company's business also includes sample management solutions and services that are used by clinical laboratories, direct-to-consumer laboratories, researchers, pharmaceutical companies, and animal health service and product providers. The revenues from sample management solutions are derived from product sales to commercial customers and sales into the academic and research markets. Customers span the disease risk management, diagnostics, pharmaceutical, biotech, and companion animal market segments. The Company has also developed collection devices for the emerging microbiome market, which focuses on studying microbiomes and their effect on human and animal health. The Company also has a urine collection device which allows for the volumetric collection of first void urine. Initial sales of this product for research use only are occurring primarily through distributors and collaborations in the liquid biopsy and sexually transmitted disease markets. In December 2025, the Company also submitted a 510(k) to the FDA for clearance of its Colli-Pee® at-home urine collection device for sexually transmitted infections, which is currently under review.

Recent Developments

Risk Assessment Testing

In the third quarter of 2024, the Company announced the discontinuance of sales of its risk assessment product line which was completed in the second quarter of 2025. Sales of its risk assessment products contributed $1.9 million and $8.4 million to revenues during the twelve months ended December 31, 2025 and 2024, respectively. During the first quarter of 2025, the Company sold certain assets that made up the risk assessment product line including certain intellectual property, contracts, permits, and equipment.

Acquisition of BioMedomics, Inc.

In November 2025, the Company acquired BioMedomics, Inc. (“BioMedomics”), pursuant to which BioMedomics became a wholly-owned subsidiary of the Company. The BioMedomics acquisition expands the Company's diagnostic portfolio by adding SickleSCAN®, a rapid, point-of-need test for sickle cell disease that is sold outside of the United States.

Table of Contents

Results of Operations

The Company's consolidated net loss for the year ended December 31, 2025 was $68.7 million, or $0.94 per share on a fully diluted basis, compared to consolidated net loss of $19.5 million, or $0.26 per share on a fully diluted basis, for the year ended December 31, 2024.

Year ended December 31, 2025 compared to December 31, 2024.

CONSOLIDATED NET REVENUES

The table below shows a summary of total consolidated net revenues (dollars in thousands) for the years ended December 31, 2025 and 2024:

For the Years Ended December 31,

Dollars

% Change

Percentage of Total Net Revenues

2025

2024

2025

2024

Diagnostics (1)

$

66,497 

$

75,917 

(12)

%

58 

%

41 

%

Sample Management Solutions (2)

38,356 

51,046 

(25)

33 

28 

Risk Assessment Testing (3)

1,866 

8,354 

(78)

2 

4 

Other products and services (4)

1,716 

2,453 

(30)

1 

1 

COVID-19 Diagnostics

620 

45,136 

(99)

1 

24 

Molecular Services

— 

1,705 

(100)

— 

1 

Net product and services revenues

109,055 

184,611 

(41)

95 

99 

Non-product and services revenues (5)

5,966 

1,216 

391 

5 

1 

Net revenues

$

115,021 

$

185,827 

(38)

%

100 

%

100 

%

(1)Includes HIV, HCV, Syphilis, and SureQuick® product revenues.

(2)Includes Genomics, Microbiome, and Colli-Pee® product revenues.

(3)Includes substance abuse testing product revenues.

(4)Includes COVID-19 Sample Management Solutions product revenues.

(5)Includes funded research and development contracts, royalty income, and grant revenues.

Product and Services Revenues    

Consolidated net revenues decreased 38% to $115.0 million for the year ended December 31, 2025 from $185.8 million for the year ended December 31, 2024.

Sales of the Company's Diagnostics products decreased 12% to $66.5 million for the year ended December 31, 2025 from $75.9 million for the year ended December 31, 2024. This decrease in revenues is largely due to lower international HIV revenues primarily driven by a decrease in funding and customer ordering patterns in Africa and Asia. Lower sales of the Company's HIV domestic products due to a decrease in overall funding impacting HIV programs also contributed to the decline in diagnostic revenues. Offsetting these decreases in revenues is an increase in Syphilis revenue resulting from the launch in the second quarter of 2024.

Sample Management Solutions revenues decreased by 25% to $38.4 million for the year ended December 31, 2025 compared to $51.0 million for the year ended December 31, 2024. Sales of the Company's Sample Management Solutions are being impacted by a large customer's bankruptcy.

Risk Assessment testing revenues decreased 78% to $1.9 million for the year ended December 31, 2025 from $8.4 million for the year ended December 31, 2024. The Company discontinued this line of business at the end of 2024 and the business wound down in early 2025.

COVID-19 Diagnostics revenues decreased 99% to $0.6 million for the year ended December 31, 2025 from $45.1 million for the year ended December 31, 2024 due to decreased sales of the Company's InteliSwab® tests through its U.S. government procurement contracts. The Company experienced a significant decline in COVID-19 revenues during 2024

Table of Contents

due to the fulfillment of these contracts and lower overall demand for COVID-19 testing and anticipates that this trend will continue into the foreseeable future.

Molecular Services revenues, which were largely derived from the Company's microbiome molecular sequencing services, were nil for the year ended December 31, 2025 compared to $1.7 million for the year ended December 31, 2024. The decrease in services revenues was due to the decision to exit this line of business.

Non-Product and Services Revenues

Non-product and services revenues increased 391% to $6.0 million for the year ended December 31, 2025 from $1.2 million for the year ended December 31, 2024 primarily due to the recognition of revenue under funded R&D contracts that were assumed by the Company as a result of the Sherlock acquisition at the end of 2024 as well as an increase in funded R&D under other BARDA contracts.

CONSOLIDATED OPERATING RESULTS

Consolidated gross profit margin decreased to 41.9% for the year ended December 31, 2025 from 42.7% for the year ended December 31, 2024. The largest driver of the margin decline was a negative product mix driven by lower InteliSwab® sales that generate higher gross margins and lower genomics sales that also generate higher gross margins. Also contributing to the decline in margins was lower absorption of fixed overhead costs due to lower revenues and production. The termination of the microbiome molecular sequencing services business which historically dragged down the gross margin rate helped to improve the gross margin rate during the period along with the higher non-product revenues which contribute 100% to gross margin.

Consolidated operating loss for the year ended December 31, 2025 was $72.0 million, compared to a $28.3 million operating loss reported for the year ended December 31, 2024. Results for the year ended December 31, 2025 were negatively impacted by the decrease in revenues, lower gross margins earned on the revenues and by higher operating expenses. Results for the year ended December 31, 2025 included change in the estimated fair value of acquisition-related contingent consideration of $4.6 million offset by gain on sale of assets of $0.7 million. Results for the year ended December 31, 2024 included impairment charges of $4.4 million.

Research and development expenses increased 63% to $42.5 million for the year ended December 31, 2025 from $26.0 million for the year ended December 31, 2024 largely due to higher spend incurred for clinical trials for the CT/NG device and additional research and development operational expense layered in from the acquired Sherlock companies.

Sales and marketing expenses decreased 16% to $26.1 million for the year ended December 31, 2025 from $31.0 million for the year ended December 31, 2024 primarily due to decreased employee costs associated with a reduction in headcount, and lower market research and advertising spend.

General and administrative expenses increased 3% to $47.7 million for the year ended December 31, 2025 from $46.2 million for the year ended December 31, 2024 largely due to higher legal fees relating to the NowDx litigation (discussed further in Note 14, Commitments and Contingencies, to the consolidated financial statements included herein) and costs associated with the Sherlock acquisition. Also contributing to the increase were additional general and administrative expenses layered in from the acquired Sherlock companies which occurred in December 2024. Lower stock compensation expense, consulting fees, and decreased employee costs partially offset the increase in general and administrative spend.

All of the above contributed to the Company's operating loss of $72.0 million for the year ended December 31, 2025, which included non-cash charges of $10.2 million for depreciation and amortization, $10.1 million for stock-based compensation, and $4.6 million for change in the estimated fair value of acquisition-related contingent consideration. The Company's operating loss of $28.3 million for the year ended December 31, 2024 included a non-cash charge of $11.9 million for stock-based compensation, $10.9 million for depreciation and amortization, and impairment charges of $4.4 million.

CONSOLIDATED OTHER INCOME

Other income for the year ended December 31, 2025 was $7.4 million compared to $12.2 million for the year ended December 31, 2024. The decrease in other income is primarily due to lower interest income and lower foreign currency gains.

Table of Contents

CONSOLIDATED INCOME TAXES

The Company continues to believe the full valuation allowance established against its total U.S. deferred tax asset is appropriate as the facts and circumstances necessitating the allowance have not changed. The Company has not achieved U.S. cumulative pre-tax earnings based on a rolling three year window as the Company has not achieved a level of sustained profitability that would, in its judgment, support the release of the valuation allowance. For the years ended December 31, 2025 and 2024, the Company recorded income tax expense of $1.8 million.

Liquidity and Capital Resources

December 31, 2025

December 31, 2024

(in thousands)

Cash and cash equivalents

$

199,278 

$

267,763 

Working capital

222,113 

299,737 

The Company's cash and cash equivalents decreased to $199.3 million at December 31, 2025 from $267.8 million at December 31, 2024. The Company has $86.9 million, or 44% of its $199.3 million of cash, cash equivalents and available-for-sale securities held by DNAG, the Company's Canadian subsidiary.

The Company's working capital decreased to $222.1 million at December 31, 2025 from $299.7 million at December 31, 2024. Working capital is primarily a function of sales, purchase volumes, inventory requirements, and vendor payment terms.

Analysis of the Company's Cash Flows

Operating Activities

During the year ended December 31, 2025, net cash used in operating activities was $49.0 million. Cash flows from operations can be significantly impacted by factors such as timing of receipts from customers, inventory purchases, and payments to vendors. The Company's net loss of $68.7 million included non-cash charges of depreciation and amortization expense of $10.2 million, stock-based compensation expense of $10.1 million, change in estimated fair value of acquisition-related contingent consideration of $4.6 million, a loss on equity investment of $2.3 million, and other non-cash charges aggregating to $1.2 million.

Cash used by the Company's working capital accounts included a decrease in accrued expenses and other liabilities of $8.7 million largely attributable to lower bonus accruals, an increase in prepaid expenses and other assets of $2.4 million associated with an increase in the Company's Canadian income tax receivable and increased prepayment of costs associated with the Company's efforts to prepare for production of the CT/NG device, a decrease of $1.7 million in accounts payable, and a decrease in deferred revenue of $1.5 million as work on grant projects is completed and earned. Offsetting these uses of cash is a decrease in inventory balances of $3.6 million related to the discontinuance of sales of the Company's Risk Assessment products and lower demand for its InteliSwab® COVID-19 Rapid test, and a decrease in accounts receivable of $1.9 million as the Company experienced a decline in overall sales.

Investing Activities

Net cash used in investing activities was $6.8 million for the year ended December 31, 2025, associated with proceeds from sale of property and equipment offset by the acquisition of new property and equipment. Investing activities also includes $3.6 million of cash used for the acquisition of BioMedomics.

Financing Activities

Net cash used in financing activities was $16.9 million for the year ended December 31, 2025, which was largely comprised of $15.0 million to repurchase common stock pursuant to the Company's stock repurchase plan and $1.8 million used for the repurchase of common stock to satisfy withholding taxes related to the vesting of restricted stock awarded to the Company's employees.

Resources

Table of Contents

The Company's contractual obligations are included in Note 14 of its consolidated financial statements. The Company expects existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements over the next twelve months. The Company's cash requirements, however, may vary materially from those now planned due to many factors, including, but not limited to, the scope and timing of future strategic acquisitions, the progress of its research and development programs, the scope and results of clinical testing, the cost of any future litigation, the magnitude of capital expenditures, changes in existing and potential relationships with business partners, the timing and cost of obtaining regulatory approvals, the timing and cost of future stock purchases, the costs involved in obtaining and enforcing patents, proprietary rights and any necessary licenses, the cost and timing of expansion of sales and marketing activities, market acceptance of new products, competing technological and market developments, the impact of the current economic environment and other factors.

Critical Accounting Policies and Estimates

This Management’s Discussion and Analysis of Financial Condition and Results of Operations discusses the Company's consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these financial statements requires that the Company make judgments and estimates that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. The Company bases its judgments and estimates on historical experience and on various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

The Company's significant accounting policies are described in Note 2 of the notes to the consolidated financial statements included in Item 15 of this Annual Report. The Company considers the following accounting policies, which have been discussed with its Audit Committee, to be most critical in understanding the more complex judgments that are involved in preparing its financial statements and the uncertainties that could impact its results of operations, financial condition, and cash flows.

Revenue Recognition

Product sales

Revenue from product sales is recognized upon transfer of control of a product to a customer based on an amount that reflects the consideration the Company is entitled to, net of allowances for any discounts or rebates.

The Company generally does not grant product return rights to its customers, except for warranty returns and return rights on sales of its OraQuick® HIV Self-Test to the retail trade, and InteliSwab® products to the retail trade and certain other customers.

Historically, returns arising from warranty issues have been infrequent and immaterial. Accordingly, the Company expenses warranty returns as incurred.

The Company records shipping and handling charges billed to the Company's customers as product revenue and the related expense as cost of products sold.

Service revenues

Service revenues represent microbiome laboratory testing and analytical services. The Company recognizes revenues when it satisfies its performance obligations for services rendered. Service revenue was discontinued with the closure of the molecular services line of business in 2024.

Arrangements with multiple-performance obligations

In arrangements involving more than one performance obligation, which largely applies to the Company's service revenue stream, each required performance obligation is evaluated to determine whether it qualifies as a distinct performance obligation based on whether (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available and (ii) the good or service is separately identifiable from other promises in the contract.

Table of Contents

The consideration under the arrangement is then allocated to each separate distinct performance obligation based on each respective relative stand-alone selling price. The estimated selling price of each deliverable is determined using an observable cost plus margin approach. The consideration allocated to each distinct performance obligation is recognized as revenue when control is transferred for the related goods or services or when the performance obligation has been satisfied.

Inventories

The Company's inventories are stated at the lower of cost or net realizable value, with cost determined on an average cost method, and include the cost of raw materials, labor and overhead. The majority of the Company's inventories are subject to expiration dating, which can be extended in certain circumstances. The Company continually evaluates quantities on hand and the carrying value of its inventories to determine the need for net realizable value adjustments for excess and obsolete inventories, based primarily on prior experience with consideration of expected changes in the business and estimated forecasts of product sales. The Company reserves for inventory expiring within ninety days, with the exception of inventory that will be consumed or will have expiration dates extended. It also considers items identified through specific identification procedures in assessing the adequacy of its reserve. Although the Company makes every effort to ensure the accuracy of its forecasts of future product demand, any significant unanticipated changes in demand could have a significant impact on the carrying value of its inventories and reported operating results.

Goodwill

Goodwill is not amortized, but rather is tested annually for impairment or more frequently if the Company believes that indicators of impairment exist. Current generally accepted accounting principles permit the Company to make a qualitative evaluation about the likelihood of goodwill impairment and if it is determined that it is more likely than not that the fair value does not exceed the carrying amount, then a quantitative test is performed. The quantitative goodwill impairment test involves a comparison of the estimated fair value of the reporting unit to the respective carrying amount. An impairment charge is recognized in the amount by which the carrying amount exceeds the reporting unit’s fair value, provided the impairment charge does not exceed the total amount of goodwill allocated to the reporting unit.

The process of evaluating the potential impairment of goodwill is highly subjective and requires significant judgment, including the identification of reporting units, qualitative evaluation of events and circumstances to determine if it is more likely than not that an impairment exists, and, if necessary, the estimation of the fair value of the applicable reporting unit.

The Company performed its annual goodwill impairment analysis and noted there were impairment indicators. A quantitative impairment test was performed on both reporting units. Both reporting units showed fair value exceeded carrying value. The diagnostic reporting unit impairment results reflected a fair value with a narrower margin to its carrying value. As of November 30, 2025, the annual impairment testing date, the diagnostic reporting unit fair value exceeded the carrying value by 13%. As of December 31, 2025, the diagnostic reporting unit had $8.2 million of goodwill. The diagnostic reporting unit goodwill impairment analysis used both an income and market approach. These two approaches were weighted and the income approach was weighed more than the market approach. Key assumptions included estimates of revenues increasing each year as new products are launched and a weighted-average cost of capital based on guideline companies. The revenue and cashflows forecasts assume products are passed by regulatory bodies on a set timeline and market competition of future products is low. The revenues assume market growth will accelerate each year. If there are delays to attaining regulatory approval or successfully launching products, this could have a negative outcome on the goodwill impairment analysis. In addition, if the Company's weighted-average cost of capital is not aligned with guideline companies, this could negatively affect the goodwill impairment outcome.

Business Combinations and Contingent Consideration

Acquired businesses are accounted for using the acquisition method of accounting, which requires that the purchase price be allocated to the net assets acquired at their respective fair values. Any excess of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill. Amounts allocated to contingent consideration are recorded to the balance sheet at the date of acquisition based on their relative fair values. The purchase price allocation requires us to make significant estimates and assumptions, especially at the acquisition date, with respect to intangible assets. Although we believe the assumptions and estimates we have made are reasonable, they are based in part on historical experience and information obtained from the management of the acquired companies and are inherently uncertain.

We account for contingent consideration in accordance with applicable guidance provided within the business combination accounting guidance. As part of our consideration for the Sherlock acquisition, we are contractually obligated to pay

Table of Contents

certain consideration resulting from the outcome of future events. Therefore, we are required to update our underlying assumptions each reporting period, based on new developments, and record such contingent consideration liabilities at fair value until the contingency is resolved. Changes in the fair value of the contingent consideration liabilities are recognized each reporting period and included in our consolidated statements of operations. Our estimates of fair value are based on assumptions we believe to be reasonable, but the assumptions are uncertain and involve significant judgment by management. Updates to these assumptions could have a significant impact on our results of operations in any given period and any updates to the fair value of the contingent consideration could differ materially from the previous estimates.

Examples of critical estimates used in valuing the intangible asset and contingent consideration include:

• future expected cash flows from sales and acquired in-process and research developed technologies;

• the probability of meeting the future events; and

• discount rates used to determine the present value of estimated future cash flows.

These estimates are inherently uncertain and unpredictable, and if different estimates were used the purchase price for the acquisition could be allocated to the acquired assets and liabilities differently from the allocation that we have made. In addition, unanticipated events and circumstances may occur, which may affect the accuracy or validity of such estimates, and if such events occur we may be required to record a charge against the value ascribed to an acquired asset or an increase in the amounts recorded for assumed liabilities.